Implementation of QRM and DoE-Based Quality by Design Approach to VEER Chromatography Method for Simultaneous Estimation
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ORIGINAL ARTICLE
Implementation of QRM and DoE-Based Quality by Design Approach to VEER Chromatography Method for Simultaneous Estimation of Multiple Combined Dosage Forms of Paracetamol Pintu Prajapati 1 & Hilomi Shah 1 & Shailesh A Shah 1
# Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Purpose Paracetamol is a well-known OTC drug, and several combinations are available in the market. The numbers of chromatography methods were published for analysis of combined pharmaceutical dosage form of paracetamol. But every combination needs separate and dedicated chromatography condition for analysis. Hence, a chromatography method was developed for simultaneous estimation of some combined pharmaceutical dosage form of paracetamol using QRM and DoEbased quality by design approach. Methods Quality risk management (QRM) was done by method risk parameter identification and assessment. The eleven potentially critical method risk parameters were screened for their main effect on the resolution of peaks by Placket Burman design. Further, three critical method risk parameters were analysed for their effect on the resolution of peaks by Box–Behnken design. Method operable design region (MODR) was navigated for optimisation of chromatography method. The chromatography method was used for simultaneous estimation of six combined dosage forms of paracetamol with different drugs. Results After QRM and DoE, mobile phase composition, the volume of acid, and plate activation temperature were found to be critical method parameters and optimised by the navigation of MODR. The optimised method gave results of the assay in agreement with the labelled claim of the dosage form. Conclusion The developed method can fulfil a requirement of six different chromatography methods for the analysis of combined dosage forms of paracetamol. Hence, the developed chromatography method is versatile, economical, eco-friendly, and robust (VEER) for the simultaneous analysis of six combined dosage forms of paracetamol. Keywords Quality by design . Quality risk management . Placket–Burman design . Box–Behnken design . VEER chromatography
Introduction Paracetamol is a widely used over-the-counter drug all over the world. The International Union of Pure and Applied Chemistry (IUPAC) name of paracetamol is N-(4hydroxyphenyl) acetanilide. Paracetamol has an antipyretic and analgesic activity. Different combined pharmaceutical dosage forms of paracetamol are available with caffeine,
* Pintu Prajapati [email protected] 1
Department of Quality Assurance, Maliba Pharmacy College, Uka Tarsadia University, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat 394350, Gujarat, India
aceclofenac, diclofenac sodium and chlorsoxazone in different strength. Caffeine acts as a central nervous system stimulant. The IUPAC name of Caffeine is 3,7-dihydro-1, 3, 7trimethyl-1H-purine-2, 6-Dione. Aceclofenac is a chemically 2- [(2, 6-dichlorophenyl) amino] phenylacetoxyacetic acid. Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID
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